EUCTR2017-000350-19-GR进行中（未招募）1 期
An open-label, randomized, phase 3 clinical trial of REGN2810 versus investigator's choice of chemotherapy in recurrent or metastatic cervical carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 534
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •The criteria listed below are not intended to contain all considerations relevant to a patient’s potential participation in this clinical trial.
- •1. Recurrent, persistent, and/or metastatic cervical cancer with squamous cell histology, for which there is not a curativeintent option (surgery or radiation therapy with or without chemotherapy).
- •a. Patients with acceptable histologies (squamous carcinoma, adenocarcinoma, and adenosquamous carcinoma (AC)) will be enrolled from the original protocol through protocol Amendment 4. For the purpose of this study, AC will be stratified as adenocarcinoma.
- •b. Starting with protocol Amendment 5, only patients with squamous cell histology are eligible to enroll.
- •2. Tumor progression or recurrence after treatment with platinum therapy (must have been used to treat metastatic, persistent, or recurrent cervical cancer).
- •3. Patient must have measurable disease as defined by RECIST
- •4. Eastern Cooperative Oncology Group (ECOG) performance status =1
- •5. =18 years old
- •6. Adequate organ or bone marrow function
- •7. Received prior bevacizumab therapy or had clinically documented reason why not administered
- •8. Received prior paclitaxel therapy or had clinically documented reason why not administered
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 427
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 107
排除标准
- •1. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments.
- •2. Prior treatment with an agent that blocks the PD-1/PD-L1 pathway.
- •3. Prior treatment with immune modulating agents (other than anti-PD-1/PD-L1 agents) within 28 days (within 90 days if there was an immune-related adverse event).
- •4. Active or untreated brain metastases.
- •5. Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of study drug cemiplimab or IC chemo) .
- •6. Active infection requiring systemic therapy.
- •7. History of pneumonitis within the last 5 years
- •8. Documented allergic or acute hypersensitivity reaction attributed to antibody treatments
- •9. History of malignancy other than cervical cancer within 3 years of first planned dose of cemiplimab, except for tumors with negligible risk of metastasis.
- •10. Prior treatment with live vaccines within 30 days of initial administration of cemiplimab. Patients must not be treated with live vaccines during the study and up to 5 half-lives following the last dose of study drug.
- •11.Patients with prior treatment on any clinical trial within 30 days of the initial administration of study drug(excepts Non-interventional and observational trials).
研究者
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